Immediate Implant Outcomes With and Without Bone Augmentation

Not Applicable

• Conditions: Tooth Loss; Dental Diseases; Dental Trauma; Bone Loss, Alveolar
• Interventions: Procedure: implant placement

• Registration Number: NCT05157009
• Lead Sponsor: Verdugo, Fernando, DDS

Brief Summary

To evaluate immediate implant placement feasibility and esthetic outcomes in severely damaged sockets that received simultaneously bone reconstruction (cortical bone shield) and implant placement versus intact sockets that needed no reconstruction and had immediate implant placement.

Detailed Description

The present clinical trial aims at demonstrating facial bone regeneration on sites that presented large buccal bone dehiscences \& vertical bone loss and evaluate the feasibility of performing simultaneous bone augmentation and implant placement, comparing the outcomes with sites that had intact sockets that did not require reconstruction. A secondary objective was to evaluate pink esthetics and marginal bone levels at final follow-up.

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-11-30
• Study First Posted: 2021-12-14
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-26
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• individuals 20 Years and older
• Patients requiring single implants to replace missing teeth to restore masticatory function and esthetics.
• ASA1 or ASA2 (American Society of Anesthesiologists)
• Healthy individuals with good oral hygiene and motivation
• No systemic uncontrolled diseases
• Not taking drugs known to modify bone metabolism

Exclusion Criteria

• Individuals with untreated & generalized severe periodontitis
• Smokers (>5 cigarettes/day)
• Poor oral hygiene
• Diabetes (HbA1C >6.5% as cutoff value)
• Uncontrolled cardiovascular disease
• Poor overall health (ASA IV)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate implant placement with reconstruction	implant placement	Immediate implant placement and simultaneous bone reconstruction after tooth extraction
Immediate implant placement without reconstruction	implant placement	Immediate implant placement after tooth extraction

Primary Outcome Measures

Name	Time	Method
Number of individuals with low pink esthetic outcomes as assessed by pink esthetic scores (PES)	12 months	pink esthetics scores (PES) as proposed by Belser et al. Values 0-10 were 10 is the best esthetic outcome.
Evaluate implant placement feasibility & success rate at 12 months	12 months	evaluate implant success following Karoussis et al. success criteria

Secondary Outcome Measures

Name	Time	Method
Number of participants with >0.2mm of marginal bone levels	12 months	evaluate radiographic marginal bone levels at 12 months with \>0.2mm of bone loss
Band of keratinized tissue: clinical presence or absence	12 months	evaluate the presence of facial keratinized tissue on the implant sites \>2 or \<2mm
Implant transparency: clinical presence or absence	12 months	Visual evaluation of facial mucosal implant transparency at 12 months: positive or negative

Trial Locations

Locations (1)

FV, DDS,Corp; 🇺🇸 San Gabriel, California, United States